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[18F]-DPA-714 PET/CT（正电子发射断层扫描/计算机断层扫描）在三阴性乳腺癌中的应用 (EITHICS)

2026年11月9日 更新者：Institut Cancerologie de l'Ouest

试点可行性研究：在三阴性乳腺癌中使用 [18F]-DPA-714 PET/CT 探索 M2 巨噬细胞的炎症和存在

This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The purpose of this study is to evaluate the correlation of inflammation assessed by M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F] DPA-714 PET imaging by using qualitative and image texture analysis in patients with triple negative breast cancer.

Patients receive pre-therapeutic diffusion-weighted breast MRI (Magnetic resonance imaging) and 18FDG (fluorodeoxyglucose) PET/CT (Positron Emission Tomography/Computerized Tomography) scan within 30 days before enrollment.

[18F] DPA-714 PET/CT scan is performed before surgery. About 3 MBq/Kg of [18F] DPA-714 are injected intravenously, two acquisition sequences are performed following injection and 60 minutes after injection in order to evaluate early and late tumor uptake of [18F] DPA-714.

Surgery is scheduled after [18F] DPA-714 PET/CT scan. Tissue samples from breast surgery are used to assess M1 and M2 macrophages expression and to perform tumor molecular subtyping by Immunohistochemical analysis. Tumor Autoradiography with the TSPO (18 kDa Translocator Protein) ligand [18F]DPA-714 will be also assessed on tumor tissue.

A blood sample is performed before [18F] DPA-714 PET/CT scan in order to assess the genotyping of TSPO (18 kDa Translocator Protein) gene.

研究类型

介入性

注册 (实际的)

13

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Paris、法国、75020
        • APHP - Hôpital Tenon
      • Saint-Herblain、法国、44805
        • Institut de cancerologie de l'Ouest
      • Tours、法国、37044
        • CHU Bretonneau

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 18 Years and older

  • Triple negative primary breast cancer based on immunohistochemical results as follows:

    • Estrogen receptor < 10%
    • And Progesterone receptors < 10%
    • And HER2 (Human Epidermal Growth Factor Receptor-2) not amplified or not overexpressed

  • Patient with a primary tumor eligible for primary surgery

  • Performance Status equal to 0 or 1

  • Fertile patients must use effective contraception

  • Patient must be affiliated to a Social Health Insurance

  • Written informed consent

Exclusion Criteria:

  • Patient with No triple negative breast cancer
  • Patient with inflammatory breast cancer
  • Patient with metastatic breast cancer
  • Patient receiving cancer treatments such as chemotherapy, immunotherapy, biologic response modifiers, hormonal therapy, and radiotherapy BEFORE the biopsy and PET scans are performed
  • Treated diabetes with fasting blood glucose > 10 mmol/L
  • Patient who received antibiotics and/or steroidal and/or non-steroidal anti-inflammatory drugs within 30 days PRIOR to [18F]-DPA-714 PET scan
  • Contraindication to MRI (implants or metallic prosthesis, severe claustrophobia, pacemaker ...)
  • Patient deprived of liberty, under a measure of safeguard of justice, under guardianship or under the authority of a guardian
  • Pregnant or nursing patient
  • Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：[18F]-DPA-714 PET/CT

[18F]-DPA-714 PET/CT scan
药品：[18F]-DPA-714

[18F]-DPA-714

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Predominance of M2-Polarized Macrophages
大体时间：2 months

Intratumoral macrophages were quantified by immunohistochemistry on surgical tumor specimens. CD68-positive cells were used to quantify the total macrophage population (M1 and M2 macrophages), whereas CD163-positive cells were used to identify M2-polarized macrophages. The percentage of M2 macrophages was calculated as the proportion of CD163-positive cells among all CD68-positive macrophages.

Results are presented as the number of participants whose tumors showed a predominance of M2-polarized macrophages.
2 months
Correlation Between % M2 Using CD163 and SUV Max [18F]DPA-714 PET/CT
大体时间：2 months

The correlation between the percentage of CD163-positive M2 macrophages (determined by immunohistochemistry) and tumor SUVmax on [18F]DPA-714 PET/CT was assessed using Spearman's rank correlation coefficient.
2 months
Correlation Between CD68-Positive Macrophage Infiltration and Tumor SUVmax on [18F]DPA-714 PET/CT
大体时间：2 months

The correlation between intratumoral CD68-positive macrophage infiltration (assessed by immunohistochemistry) and tumor SUVmax on [18F]DPA-714 PET/CT was evaluated using Spearman's rank correlation coefficient.
2 months

次要结果测量

结果测量
措施说明
大体时间
Distribution of [18F]DPA-714 PET/CT Tumor Uptake Patterns According to TSPO Genotype (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder)
大体时间：2 months

Tumor uptake patterns were classified as above, equal to, or below muscular background and are presented descriptively according to TSPO genotype (HAB, MAB, LAB). No formal statistical analysis was performed because of the limited sample size.
2 months
Slope of Tumor Time-Activity Curves During Early [18F]-DPA-714 PET/CT Acquisition
大体时间：1 month

Early tumor uptake was assessed using dynamic PET/CT time-activity curves (TACs). Results are presented as the slope of tracer accumulation derived from tumor TACs. Tumors were classified relative to the contralateral pectoral muscle as above muscular, equal to muscular, or below muscular background.
1 month
Primary Tumor Detection by [18F]-DPA-714 PET/CT, 18F-FDG PET/CT, and Diffusion-Weighted Breast MRI
大体时间：1 month

Primary tumor detection was assessed qualitatively using [18F]-DPA-714 PET/CT, 18F-FDG PET/CT, and diffusion-weighted breast MRI. Results are presented as the number of participants in whom the primary tumor was identified by each imaging modality.
1 month
[18F]-DPA-714 Toxicity
大体时间：1 month

Number of patients with adverse events and serious adverse event after [18F]-DPA-714 administration
1 month
Tumor SUVmean During Late [18F]-DPA-714 PET/CT Acquisition
大体时间：1 month

Late tumor uptake was assessed during the plateau phase of dynamic [18F]-DPA-714 PET/CT time-activity curves (TACs). Tumors were classified relative to the contralateral pectoral muscle as above muscular, equal to muscular, or below muscular background. Results are presented as median SUVmean values and ranges for each uptake pattern.
1 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Institut Cancerologie de l'Ouest

合作者

SIRIC ILIAD

调查人员

  • 首席研究员：Caroline ROUSSEAU, MD, PhD、Institut de Cancerologie de l'Ouest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月11日

初级完成 (实际的)

2021年7月21日

研究完成 (实际的)

2021年7月21日

研究注册日期

首次提交

2020年2月20日

首先提交符合 QC 标准的

2020年3月23日

首次发布 (实际的)

2020年3月24日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ICO-N-2019-04

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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